FDA.reportPublic FDA data

Hand Screen Broad Spectrum Sunscreen SPF 40

Product NDC
75936-151
11-digit product format
759360151
Labeler code
75936
Product ID
75936-151_47f864fd-a285-bc1d-e063-6294a90aa32d
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Supergoop, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-12
Substance
OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength
5; 3; 10 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Hand Screen Broad Spectrum Sunscreen SPF 40
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE5 g/100mL
AVOBENZONE3 g/100mL
OCTOCRYLENE10 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
972ebab9-3f2f-6716-e053-2a95a90a5c75Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75936-151-01Hand Screen Broad Spectrum Sunscreen SPF 404 mL in 1 BOTTLELOTION48
75936-151-02Hand Screen Broad Spectrum Sunscreen SPF 4030 mL in 1 BOTTLELOTION308
75936-151-03Hand Screen Broad Spectrum Sunscreen SPF 40200 mL in 1 BOTTLELOTION2008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75936-151HAND SCREEN BROAD SPECTRUM SUNSCREEN SPF 40 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) LOTION [SUPERGOOP, LLC]7Current NDC, Legacy NDC, 3 package rows20241207_972ebab9-3f2f-6716-e053-2a95a90a5c75.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 226 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOLA Firming Face Serum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUMCOOLA LLC85fd7ef4-ed08-4a69-8293-5f3f3d264c042025-03-06WarningsExact identifier
application number: M020
GOLDEN HOUR HYDRATING SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.090b5861-20f5-43c6-aff6-d17d61e8568e2025-03-04WarningsExact identifier
application number: M020
Aveeno Baby continuous protection sensitive skin Sunscreen Broad Spectrum SPF50ZINC OXIDEKenvue Brands LLCbbd6710f-a665-437e-b86b-437f732984d12025-03-04WarningsExact identifier
application number: M020
LBEL DIVINE DOUBLE USE LONGWEAR 36H SPF 15 CREME 110OCTINOXATE, ZINC OXIDEBELSTAR S.A.2f8607c5-b5ab-ed81-e063-6394a90a34532025-03-04WarningsExact identifier
application number: M020
ADVANCED PROTECTION SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f8bbd08-d199-03bd-e063-6294a90adfac2025-03-04WarningsExact identifier
application number: M020
MINERAL TINTED SPF 30TITANIUM DIOXIDE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f9e2252-fb54-363f-e063-6294a90aa7c92025-03-04WarningsExact identifier
application number: M020
LBEL LUMI-AGE ANTI-AGING HYDRATING DAY FACIAL SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR S.A.2f717492-347d-5bf8-e063-6294a90a4b5f2025-03-03WarningsExact identifier
application number: M020
CoTZ Kids Mineral Sun StickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2f7225d0-ddfa-e19a-e063-6294a90a52a82025-03-03WarningsExact identifier
application number: M020
Sum 37 Micro Active Daily Moisture SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.2eea94e1-2409-8ad6-e063-6294a90a5df82025-03-03WarningsExact identifier
application number: M020
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21c9f9-acf8-997b-e063-6394a90ada3f2025-03-01WarningsExact identifier
application number: M020
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e232e8d-4274-68bc-e063-6394a90a942b2025-03-01WarningsExact identifier
application number: M020
Sun Defense Minerals (Deep)ZINC OXIDEEminence Organic Skin Care2e23d463-fbc1-5718-e063-6294a90a72722025-03-01WarningsExact identifier
application number: M020
Sun Defense Minerals (Deep)ZINC OXIDEEminence Organic Skin Care2e24391f-4982-efae-e063-6394a90accaa2025-03-01WarningsExact identifier
application number: M020
FRUDIA Blueberry Hydrating Air Fit SunscreenOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEWELCOS CO.,LTD.8b2a1baa-e528-48d6-9cd8-c3cb55e0641b2025-02-28WarningsExact identifier
application number: M020
BRUSH ON BLOCK SPF 50 MINERALZINC OXIDESPF Ventures, LLC2f1b5454-8bf5-b447-e063-6394a90a743a2025-02-27WarningsExact identifier
application number: M020
Clear Defense SPF 45ZINC OXIDE, OCTINOXATEPrivate Label Skin Cared681d92f-3501-4fca-b629-096341f20ab12025-02-27WarningsExact identifier
application number: M020
HA Physical Tint SPF 44ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea5e19d77-703e-41e0-9a02-19227dc6c8192025-02-27WarningsExact identifier
application number: M020
Physical Daily Defense Broad Spectrum Sunscreen SPF 40ZINC OXIDEPrivate Label Skin Care18444581-66a4-4eda-a8df-627fa3b4b98a2025-02-26WarningsExact identifier
application number: M020
BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILLZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC2f069114-9ca8-aed4-e063-6394a90a46d82025-02-26WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream230 NMelaleuca Inc.2f133abb-cad2-2ac8-e063-6294a90aa4802025-02-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75936-151-01759360151014 mL in 1 BOTTLE (75936-151-01) 4 ml2019-11-120000-00-00NoNoCurrent
75936-151-027593601510230 mL in 1 BOTTLE (75936-151-02) 30 ml2019-11-120000-00-00NoNoCurrent
75936-151-0375936015103200 mL in 1 BOTTLE (75936-151-03) 200 ml2019-11-120000-00-00NoNoCurrent